Effect of Prophylactic Antibiotics on Intra-Operative Culture Results
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|ClinicalTrials.gov Identifier: NCT01174212|
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : August 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Infection Arthroplasty||Procedure: Prophylactic Antibiotics Procedure: Control Antibiotics||Phase 4|
It is unknown whether giving pre-operative antibiotics affects the results of intraoperative bacterial cultures. This is an important question as antibiotics are often not given prior to surgery out of concern that accurate culture results will not be obtained. It is important to obtain accurate cultures so that targeted antibiotic therapy can be used. However, delaying the administration of antibiotics also delays the onset of treatment. Currently, the optimal course of action is unknown. The purpose of this study is to resolve this issue and determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection.
This is a prospective randomized clinical study to determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection. Pre-operatively, patients will have their affected joint aspirated and this fluid will be sent for cultures. Patients are then randomized to receive prophylactic antibiotics (Vancomycin and Ancef) within one hour prior to surgery or to have pre-operative antibiotics withheld. Every patient then has their affected joint cultured intra-operatively. All samples will be evaluated for the presence of aerobic bacteria, anaerobic bacteria, mycobacteria, and fungus. Pre-operative and post-operative cultures in both study populations are compared to determine the effects of pre-operative antibiotics.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Prophylactic Antibiotics on Intra-Operative Culture Results|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2012|
Patients receiving antibiotics approximately 1 hour prior to incision are considered to be in the experimental group of this study.
Procedure: Prophylactic Antibiotics
Control group is to receive no antibiotics until the intraoperative cultures have been obtained.
Procedure: Control Antibiotics
Antibiotics will be held until intraoperative cultures have been obtained.
- Changes in cultures obtained preoperatively and intraoperatively [ Time Frame: 1 year ]Patients suspected of having an infected total hip or knee replacement in the post-operative period will be evaluated clinically. Preoperative and intraoperative revision cultures will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174212
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Craig Della Valle, MD||Rush University Medical Center|